NCT07478289

A Phase II Trial Evaluating Radiation Boost to Painful Spinal Metastases

OPTimized Dose Escalation With Simultaneous Integrated Boost for High Risk Spinal Metastases: a Prospective Phase II TriAL (OPTIMAL)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Spine SBRT is considered a standard of care for the treatment of spinal metastases. Compared to conventional radiation therapy, spine SBRT delivers high doses of radiation to the affected areas to the spinal metastases. This study is interested in seeing whether an additional 'boost' of radiation, delivered to the affected area in the spine, will result in better long-term control of the tumor; help reduce pain; and reduce long-term side effects of radiation therapy.

Conditions

• Spine Metastasis

Interventions

Type	Name	Description
RADIATION	Radiation Boost	An additional boost of radiation will be delivered to the spinal metastases. The amount of boost depends on how much radiation would have been normally prescribed (e.g., if treatment required 2 fractions of radiation treatment, an additional 2 Gy would be prescribed; if treatment required 4 fractions of radiation treatment, an additional 4 Gy would be prescribed; if treatment required 5 fractions of radiation treatment, an additional 5 Gy would be prescribed).

Timeline

• Start date: 2026-04-01
• Primary completion: 2029-12-01
• Completion: 2031-12-01
• First posted: 2026-03-17
• Last updated: 2026-03-17

Locations

1 site across 1 country: Canada